Posted on: January 16, 2022
This is where you save and sustain livesAt Baxter, we are deeply
connected by our mission. No matter your role at Baxter, your work
makes a positive impact on people around the world. You'll feel a
sense of purpose throughout the organization, as we know our work
improves outcomes for millions of patients.Baxter's products and
therapies are found in almost every hospital worldwide, in clinics
and in the home. For over 85 years, we have pioneered significant
medical innovations that transform healthcare.Together, we create a
place where we are happy, successful and inspire each other. This
is where you can do your best work.Join us at the intersection of
saving and sustaining lives- where your purpose accelerates our
mission.SummaryThe Quality Associate I Line Operations is a member
of the Quality Assurance Line Operations Team reporting directly to
the Quality Supervisor. They maintain quality oversight of the
manufacturing areas by working closely with manufacturing personnel
and performing various checks during manufacturing processes. They
also assess regulatory and quality risks in activities and
processes according to regulatory agency rules and guidelines and
Baxter Standard Operating Procedures. This position strives for
continuous improvement of processes and contributes to creating an
environment where teamwork, productivity, safety, identity,
strength, purity and quality (SISPQ) are reflected in the finished
product. This opening is on the 2nd shift with a work schedule of
Monday through Friday.Essential Duties and Responsibilities (these
are primary responsibilities of the role and the incumbent will
perform other duties as assigned)
- Ensures compliance with all worldwide regulatory agency
requirements and company-specific regulations related to quality of
product and employee safety.
- In-process review of records to ensure they are complete,
accurate and compliant with current Good Manufacturing Practices
(cGMP) requirements. Records include batch records and other
documents involved in the aseptic processing of drug product.
- Reports errors, deficiencies, discrepancies and observations to
management. May stop operations when product safety is or may be
- Performs Quality functions in classified areas, including
production oversight, manufacturing process assessments, aseptic
intervention oversight, and line clearances.
- Reviews completed terminal sterilizer, lyophilizer,
depyrogenation, and autoclave charts.
- Provides review of completed work orders and proposed standard
operating procedure revisions.
- Works in collaboration with management teams to prepare for
internal and external audits. Assists with timely closure of audit
observations and CAPAs.
- Initiates and authors Nonconformance Reports and corrective and
preventative action responses.
- Conducts bi-annual inspections of classified areas in
preparation for facility shutdown periods.
- Initiates standard operating procedure (SOP) revisions as
needed to support continuous improvement.
- Ensures that SOPs are current and effective and that staff
performs routine tasks according to SOP through direct
- Bachelor's degree in a science discipline, or Bachelor's degree
in non-science discipline with at least three years of
Pharmaceutical Quality or Manufacturing experience
- Computer proficiency in Microsoft Word, Excel, and Outlook and
the ability to use enterprise software (examples include: JDE,
BPLM, Pilgrim, Trackwise, etc.)Physical / Safety Requirements
- Must wear appropriate PPE as required for various manufacturing
- Must be able to gown qualify for Grade A/B areas.
- Duties will require overtime work, including scheduled weekend
- Use of hands and fingers to manipulate office equipment is
- Position requires sitting for long hours, but may involve
walking or standing for periods of time#IND-USOPS#LI-LH1Equal
Employment OpportunityBaxter is an equal opportunity employer.
Baxter evaluates qualified applicants without regard to race,
color, religion, gender, national origin, age, sexual orientation,
gender identity or expression, protected veteran status,
disability/handicap status or any other legally protected
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency PolicyReasonable Accommodations
Baxter is committed to working with and providing reasonable
accommodations to individuals with disabilities globally. If,
because of a medical condition or disability, you need a reasonable
accommodation for any part of the application or interview process,
please click on the link here and let us know the nature of your
request along with your contact information.Recruitment Fraud
Baxter has discovered incidents of employment scams, where
fraudulent parties pose as Baxter employees, recruiters, or other
agents, and engage with online job seekers in an attempt to steal
personal and/or financial information. To learn how you can protect
yourself, review our Recruitment Fraud Notice.045311
Keywords: BAXTER, Bloomington , Quality Associate, Other , Bloomfield, Indiana
Didn't find what you're looking for? Search again!